Effect of Prontosan Wound Irrigation Solution on Venous Ulcers

Wound Care Clinical Trial

Official title: Randomised, Controlled, Clinical Trial on the Safety and Efficacy of Prontosan Wound Irrigation Solution Compared to Standard Therapy in the Treatment of Hard-to-Heal Venous Leg Ulcers

Status Completed

Clinical Trial Summary

Objective:

To evaluate the efficacy and safety of Prontosan® Wound Irrigation Solution in the treatment of hard-to-heal venous leg ulcers compared to wound irrigation with saline solution

Methodology:

Randomised, controlled multi-centre, prospective clinical trial

Planned number of subjects:

20 patients in experimental group (Prontosan® Wound Irrigation Solution) 8 patients in control group (wound irrigation with saline)

Products under investigation:

Prontosan® Wound Irrigation Solution

Study Duration:

3-4 weeks

Clinical Trial Description

Investigational product, dose and administration:

Prontosan® Wound Irrigation Solution (experimental group) and saline solution (control group) will be applied at inclusion and reapplied after dressing changes.

The treatment scheme is as follows:

1. Prontosan® Wound Irrigation Solution (experimental group):

• cleansing the wound bed at dressing change with Prontosan® Wound Irrigation Solution; a sterile gauze dressing impregnated with the Prontosan® solution will be placed on the immediate wound in the form of a moist compress and removed after approximately 15 minutes;

• placing the primary dressing (Profore® WCL): the dressing will be impregnated with Prontosan® Wound Irrigation Solution;

• fixing the dressing to the wound using multilayered elastic compression bandaging (Profore® bandaging system).

2. Saline (control group):

• cleansing the wound bed at dressing change with saline; a sterile gauze dressing impregnated with the saline will be placed on the wound in the form of a moist compress and removed after approx.15 minutes;

• placing the primary dressing (Profore® WCL): the dressing will be impregnated with saline;

• fixing the dressing to the wound using multilayered elastic compression bandaging (Profore® bandaging system).

Dressings will be changed and the treatment procedure will be repeated in the clinic 2x/weekly or more. The efficacy of the treatment procedure will be evaluated on the basis of a 2 week observation period.

Treatment efficacy assessment:

• Assessment of clinical signs and symptoms at entry to the study and after one and two weeks.

• Quantitative and qualitative microbiological analysis at entry to the study and after two weeks.

• Wound planimetry using PictZar® CDM at entry to the study and after two weeks.

Primary aim:

• clinical signs assessed by:

1. reduction of slough and necrotic tissue

2. control of exudate

3. presence of granulation tissue

• reduction of inflammatory signs (surrounding skin)

• reduction in wound size (assessed by wound planimetry)

• reduction of bacterial load (quantitative and qualitative microbiological

Secondary aim:

• tolerance and safety assessment:

1. adverse drug reaction

2. adverse events

3. early withdrawal from the study ;

Related Conditions & MeSH terms

• Chronic Wound Care
• Ulcer
• Varicose Ulcer
• Venous Ulcer Care
• Wound Care
• Wound Cleansing
• Wounds and Injuries

• NCT number: NCT01048307
• Study type: Interventional
• Source: Calvary Hospital, Bronx, NY
• Status: Completed
• Phase: N/A
• Start date: June 2009
• Completion date: July 2010